PITTSBURGH, Nov. 23, 2020 /PRNewswire/ -- Viatris
Inc. (NASDAQ: VTRS), a new kind of healthcare company,
today announced tentative approval from the U.S. Food and Drug
Administration (FDA) for a New Drug Application for pediatric
dolutegravir tablets for oral suspension, 10 mg. The new
formulation is a result of a collaboration with ViiV Healthcare,
the Clinton Health Access Initiative and Unitaid to help expand
access to children living with HIV/AIDS in low- and middle-income
countries. Tentative approval was granted under the U.S.
President's Emergency Plan for AIDS Relief (PEPFAR) which permits
products that are not approved for marketing in the U.S. because of
patent protection or other marketing restrictions to be distributed
in other countries where they are critically needed.
Pediatric dolutegravir tablets were approved for use in
combination with other antiretroviral (ARV) agents for the
treatment of HIV-1 infection in pediatric patients at least 4 weeks
old and weighing at least 3 kg. The World Health Organization (WHO)
recommends this product as part of a preferred first-line treatment
regimen for children who meet the criteria. According to the
organization, half of HIV-positive infants will die before their
second birthday without prompt diagnosis and treatment.
Viatris President Rajiv Malik
said, "The FDA's decision clears the way for Viatris to deliver
this urgently needed treatment to some of the world's most
vulnerable children living in regions that are home to 99% of
children living with HIV. Pediatric dolutegravir tablets are a
significant new addition to a product portfolio that has made
Viatris the world's largest supplier of ARVs. We have a deep
commitment to increasing access to more affordable treatments and
will continue to find innovative solutions to reach those in
need."
Dolutegravir tablets for oral suspension should not be
co-administered with dofetilide; it may cause hypersensitivity
reactions; hepatotoxicity has been reported in patients receiving
dolutegravir-containing regiments and embryo-fetal toxicity may
occur when used at the time of conception and in early
pregnancy.
Viatris, launched last week through the combination of Mylan
N.V. and Pfizer's Upjohn business, provides approximately 40% of
those on treatment for HIV/AIDS with a Viatris product, including
approximately 60% of the world's HIV-positive children on
treatment.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company,
empowering people worldwide to live healthier at every stage of
life. We provide access to medicines, advance sustainable
operations, develop innovative solutions and leverage our
collective expertise to connect more people to more products and
services through our one-of-a-kind Global Healthcare
Gateway™. Formed in November 2020 through the
combination of Mylan and Pfizer's Upjohn business, Viatris brings
together scientific, manufacturing and distribution expertise with
proven regulatory, medical and commercial capabilities to deliver
high-quality medicines to patients in more than 165 countries and
territories. Viatris' portfolio comprises more than 1,400 approved
molecules across a wide range of therapeutic areas, spanning both
non-communicable and infectious diseases, including globally
recognized brands, complex generic and branded medicines, a growing
portfolio of biosimilars and a variety of over-the-counter consumer
products. With a global workforce of approximately 45,000, Viatris
is headquartered in the U.S., with global centers
in Pittsburgh, Shanghai and Hyderabad,
India. Learn more
at viatris.com and investor.viatris.com, and connect
with us on Twitter
at @ViatrisInc, LinkedIn and YouTube.
Forward-Looking Statements
This press release
includes statements that constitute "forward-looking statements,"
including with regard to Viatris™ announcing FDA tentative approval
of a pediatric formulation of DTG under PEPFAR, that tentative
approval will help enhance access to WHO-recommended pediatric
medicine and reduce the cost of HIV treatment for children in low-
and middle-income countries; and statements about the
transaction pursuant to which Mylan N.V. combined with Pfizer
Inc.'s Upjohn business (the "Combination") to form Viatris. These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Because
forward-looking statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such statements. Factors that could
cause or contribute to such differences include, but are not
limited to: the potential impact of public health outbreaks,
epidemics and pandemics, including the ongoing challenges and
uncertainties posed by the COVID-19 pandemic; the integration of
Mylan and the Upjohn Business being more difficult, time consuming
or costly than expected; the ability to achieve expected
benefits, synergies and operating efficiencies in connection with
the Combination within the expected timeframe or at all or to
successfully integrate Mylan and the Upjohn Business; actions and
decisions of healthcare and pharmaceutical regulators; changes in
healthcare and pharmaceutical laws and regulations in the U.S. and
abroad; any regulatory, legal or other impediments to Viatris'
ability to bring new products to market; Viatris' or its partners'
ability to develop, manufacture and commercialize products; the
scope, timing and outcome of any ongoing legal proceedings and the
impact of any such proceedings; any significant breach of data
security or data privacy or disruptions to our information
technology systems; risks associated with international operations,
including our operations in China;
the ability to protect intellectual property and preserve
intellectual property rights; changes in third-party relationships;
the effect of any changes in Viatris' or its partners' customer and
supplier relationships and customer purchasing patterns; the
impacts of competition; changes in the economic and financial
conditions of Viatris or its partners; uncertainties and matters
beyond the control of management; and the other risks Viatris'
filings with the Securities and Exchange Commission. Viatris
routinely uses its website as a means of disclosing material
information to the public in a broad, non-exclusionary manner for
purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris
undertakes no obligation to update these statements for revisions
or changes after the date of this release other than as required by
law.
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SOURCE Viatris Inc.